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Unknown statusPhase 2

The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.

NCT04433845 · Sheppard Pratt Health System

Closed to entry
Status
Not accepting participants
Phase 2
Phase
15
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The primary objective of this study is to evaluate the efficacy of 25 mg of psilocybin under supportive conditions to adult participants with BP-II, current episode depressed, in improving depressive symptoms.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Montgomery-Asberg Depression Rating Scale (MADRS)

    Measured over From Baseline (Day -1) to three weeks post-dose.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Diagnosis of Type 2 Bipolar Disorder (BP-II) Depression Exclusion Criteria: * Comorbidities

Where

1 study site

FacilityCityRegionCountry
Sheppard PrattBaltimoreMarylandUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04433845 on ClinicalTrials.gov →

Last updated in the registry 2022-10-25. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits